Using Red Yeast Rice to Prevent High Cholesterol

Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Red Yeast Rice for Primary Prevention of Hypercholesterolemia: A Pilot Observational Study

This study is testing if taking LipoCol Forte Capsules can help men aged 35 to 55 prevent high cholesterol over two years.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 35 Years to 55 Years
• Sex: Male
• Sponsor: Chang Gung Memorial Hospital (other)
• Locations: 1 site (Taoyuan)
• Trial ID: NCT06301906 on ClinicalTrials.gov

What this trial studies

This observational study will take place over two years at the outpatient clinic of the Department of Traditional Chinese Medicine at Taoyuan Chang Gung Hospital. It aims to enroll male patients aged 35 to 55 who will take LipoCol Forte Capsules for the primary prevention of hypercholesterolemia. Researchers will collect various health data, including blood samples and questionnaires, to assess the efficacy, safety, and durability of the treatment. The study will also analyze fecal samples to understand the impact on intestinal microbiota and bile acid composition.

Who should consider this trial

Good fit: Ideal candidates are males aged 35 to 55 with elevated LDL cholesterol levels or diabetes/chronic kidney disease.

Not a fit: Patients with a history of coronary heart disease, myocardial infarction, or cerebrovascular disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new preventive approach for managing cholesterol levels in at-risk individuals.

How similar studies have performed: While there have been studies on red yeast rice, this specific observational approach focusing on primary prevention is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Aged 35\~55 years old, LDL-C≥130mg/dl or patients with diabetes or chronic kidney disease with LDL-C ≥ 100mg/dl, expected to receive LipoCol Forte Capsule 600mg bid

Exclusion Criteria:

1. Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month;
2. Female;
3. Have experienced rhabdomyolysis or abnormal liver function ALT \>72 U/L due to taking red yeast rice;
4. Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month
5. Liver insufficiency ALT \>72 U/L or renal insufficiency eGFR \< 30 mL/min/1.73 m2;
6. Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease;
7. Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated;
8. Uncontrolled hypertension (blood pressure ≥160/100 mmHg);
9. Use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study;
10. Drug abuse or poor compliance;
11. Use of traditional Chinese medicine in the past month

Where this trial is running

Taoyuan

• Taoyuan branch of Chang Gung Memorial Hospital — Taoyuan, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Yueh Hsiang Huang, PhD

Conditions: Hypercholesterolemia